Design, Development, and Consistency of a Hand Held Tibio-Fibular Torsion Device

Institutional Review Board, Hospital for Special Surgery

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Corinne McCarthy, PT, DPT, MS

Co-Investigators

Howard J. Hillstrom, Ph.D
Sherry Backus, PT, DPT, MA
David M. Scher, MD
Leon Root, MD

Summary

20 patients (10 adults, 10 children), enrollment period: ongoing up to 1 year.

Inclusion/Exclusion Criteria

The subjects of this study will consist of two groups of healthy, asymptomatic volunteers: 1) Adults (19 to 85 years old) and 2) Children (7 to 18 years old).   

Contact Information

Corinne McCarthy, PT, DPT, MS
212.606.1215